| Project Scope |
|---|
| Development and delivery of education relevant to clinical trial safety analyses, with a focus on Phase 2-3. |
| Problem Statement |
|---|
Planning and interpreting clinical trial safety analyses demands scientific expertise that is often missing in educational curricula. The Safety Analytics field is dynamic and evolving, requiring continual learning. All the roles (for example, medical, statistics, writers) that collaborate on ongoing safety reviews, clinical study reports and integrated submission documents can improve their planning, content, execution, and communication of clinical trial safety analyses. |
| Problem Impact |
|---|
Improving Safety Analytics Education will lead to better content, implementation, and understanding of clinical trial safety analyses. Additionally, when stakeholders are educated, less time is needed for aligning on analysis plans and data interpretations. Members of the Safety Analytics Education project team have been active in delivering and promoting educational content for a while:
The Education project team will provide a dedicated channel for future efforts and enhance the standing of PHUSE in the safety analytics space. |
Project Leads | Emails |
|---|---|
Christopher Smith, FDA | |
William Palo, |
AbbVie | |
Nicola Newton, PHUSE Project Assistant |
|
|---|
Q2 2024 |
|---|
|
Objectives & Deliverables | Timelines |
|---|
Enhance the existing Safety Analytics Education website | Ongoing |
Deliver webinars on safety content | Ongoing |
| Education Resources: |
|---|
| Education Page |
| Reimagining a Safety Submission – Vision of Interactive Safety Reviews |
Date
Title
Speakers
Recording
15 June
Greg Ball, ASAP Process Consulting, Mac Gordon, Johnson & Johnson), Peg Fletcher, MedAssessment & Scott Proestel, FDA
Jeremy Wildfire, Gilead, Steve Mallett, Veramed & Mat Soukup, FDA/CDER
Greg Ball, ASAP Process Consulting, Jacqueline Corrigan-Curay, FDA, Barbara Hendrickson, University of Chicago & Sheila Mahoney-Jewels, LifeSciHub